HOUDA ADLOUNI
PARIS
Summary
A dedicated Quality Management professional with 15 years of experience, with successful career in the pharmaceutical industry. Creates successful quality assurance strategies and processes. Skilled in enhancing products and processes through meticulous inspections and comprehensive data analysis. Experienced performing both process and outbound inspections. Accomplished at identifying deficiencies and initiating solutions to problems.
Demonstrates outstanding attention to detail and critical thinking, effectively managing quality management systems. Possesses excellent communication skills, active listening, and organizational abilities. Adaptable and physically fit, capable of thriving in diverse work environments.
Drives smooth operation of production and manufacturing lines, coordinate efforts of employees and facilitate communication between management and production departments. Apply creativity in improving manufacturing process to achieve higher productivity and quality of finished goods. Experience in reviewing and interpreting regulatory and programmatic guidance, implementation of corporate compliance, risk management and corrective action programs.
Overview
16
16
years of professional experience
Work History
Quality Director
LABEPIC Consulting
01.2020 - Current
- Determined quality department standards, practices, and procedures.
- Tracked quality issues with external customers, suppliers, and internal plant operations.
- Applied coaching techniques and tools to support managers and team members in improving performance.
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
- Established and tracked quality department goals and objectives.
- Specified quality requirements of raw materials with suppliers.
- Inspected products and worker progress throughout production.
- Assured consistent quality of production by implementing and enforcing automated practice systems.
- Implemented new quality assurance and customer service standards.
- Monitored staff organization and suggested improvements to daily functionality.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Reported production malfunctions to managers and production supervisors.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
- Worked well in a team setting, providing support and guidance.
- Passionate about learning and committed to continual improvement.
- Self-motivated, with a strong sense of personal responsibility.
- Developed and maintained courteous and effective working relationships.
- Demonstrated creativity and resourcefulness through the development of innovative solutions.
- Skilled at working independently and collaboratively in a team environment.
CMO Quality Manager
GSK
01.2018 - 01.2020
- Ensure that all aspects of the products manufactured at the subcontracting sites comply with regulations, Apply the appropriate risk management tools with each CMO/external supplier concerned
- Monitor significant risks requiring resolution, including monitoring of complaints and trends,
- Ensure that investigations associated with assigned third-party sites are properly conducted, resulting in sustainable, documented, evaluated and closed CAPAs,
- Ensure timely communication of quality alert issues of any assigned deviations, changes control, audit remarks or claims that may have an impact on the product released on the market,
- Conduct root cause analysis reviews for problem identification and corrective actions,
- Work with the CMO to establish meaningful CAPAs in response to audit observations, Supporting introductions of new products from an operational point of view
- Implemented key initiatives and activities aligned with business strategy.
- Completed and submitted monthly and yearly reports to support executive decision making.
- Managed relationships with key industry partners and implemented promotional initiatives to maximize marketing program performance.
Quality Assurance Manager
Atlas Pharm Tecnimede Group
01.2017 - 07.2018
- Designed and implemented a Quality Assurance policy,
- Contributed to the validation strategy — qualification, Ensuring QMS compliance with applicable standards (GMP, BPD, ISO...),
- Supervised audits, inspections and quality training,
- Supervised the declination of quality management at all levels of the company,
- Contributed to the monitoring of storage conditions of the production environment as a whole,
- Recorded, analyzed, and distributed statistical information.
- Monitored staff organization and suggested improvements to daily functionality.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
- Performed root cause analysis to identify and resolve quality issues and defects.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Investigated customer complaints and performed corrective actions to resolve quality issues.
- Tracked quality issues with external customers, suppliers, and internal plant operations.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
Quality Assurance Coordinator
SOTHEMA
04.2013 - 03.2017
- Evaluated accuracy of existing quality assurance measurement techniques, implementing improvements to increase efficacy and reduce errors.
- Drafted reports on quality verification activity outcomes, presenting findings to decision-makers and recommending response efforts.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Contributed to process Validation for (dry forms; solutions, injectables etc.),
- Involved in the preparation and follow-up of external audits: Management of customer CAPA audits and inspections by health authorities: ANSM, Dutch authorities, Saudi Arabian GCC Authority, etc.,
Primary packaging team leader
Sanofi Aventis
01.2012 - 03.2013
- Optimized production processes (Lean, SMED),
- Define production objectives, supervised of operator teams, Reviewed of batch records,
- Rationalized the means of production with a view to controlling costs and adapting existing resources (work teams, equipment, implementation of information systems),
- Planed investment plans related to improving the organization in terms of quality, safety and productivity,
- Managed load rates: identification and resolution of breakdowns, coordination of activities related to production (quality, safety, management of subcontracting and maintenance services),
- Created and managed project plans, timelines and budgets.
- Established open and professional relationships with team members to achieve quick resolutions for various issues.
- Assisted in recruitment to build team of top performers.
- Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
- Developed effective improvement plans in alignment with goals and specifications.
Process Engineer
Sanofi Aventis
08.2008 - 01.2012
- Provided technical assistance to production team when issues arose.
- Led root cause analyses to identify and address problems in industrial production.
- Analyzed data to identify trends in production and maintenance costs and developed strategies to reduce expenses.
- Created and implemented project plans for new or improved industrial processes.
- Conducted evaluations of equipment and machinery to verify optimal performance and efficiency.
- Developed and implemented process improvements to reduce costs and increase efficiency in industrial production.
- Designed, created and tested production models for industrial processes.
- Collaborated with cross-functional teams to develop and implement process changes.
- Monitored and optimized production processes to increase throughput and improve quality.
- Managed third-party contractors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
- Met weekly with team members to discuss project implementations and alleviate any issues.
- Reviewed processes, identifying areas requiring improvement.
- Interfaced with area teams to verify application of technical details.
- Prepared scope of work documentation for use in project planning
- Learned about experimental design principles and methods for controlling variables in studies.
- Used experimental design, research, analysis and interpretation of data to determine feasibility and efficacy of proposed solutions.
- Conducted root cause analysis to identify, prioritize and eliminate process losses.
- Developed documentation, diagrams, and specifications to meet project requirements and regulatory standards.
Education
Master of Science - Pharmacology
FACULTE DE PHARMACIE PARIS V
PARIS06.2008
Bachelor of Science - Biochemistry
FACULTÉ FRANCHE COMPTE UFR Sciences Et Techniques
BESANCON07.2005
Skills
- Proven team leadership and management skills
- Improvement tracking
- Lean environments
- Document management
- Management of deviations
- CAPA management
- Change control management
- Training management
- Equipment qualification
- Qualification of suppliers/subcontractors
- Experience in conducting inspections of authorities (CCG, ANVISA, INFARMED, FDA, ANSM)
- Project management
- Knowledge of pharmaceutical regulations
- Experience manufacturing dry forms
- Conducting supplier audits for APIs and sub-processors
- Multi-departmental project management
- Oversees missions by providing feedback to teams on a daily basis
- Strength of proposal and spirit of undertaking
- Sets priorities for action and allocation of resources/resources/delays and procedures to be followed in case of malfunction and validates operational action plans
- Standards
- CGMP FDA 21 CFR Part 11 (electronic records, electronic signature); GAMP
- CGMP FDA (21 CFR part 210-211)
- GPF, GMP Europe GDP
- Clean rooms and related controlled environment (ISO 14644-1, 2, 3, 4), cleanroom classification (ISO)
- ISO 2859-1, ISO 17025
- ICH
- Tools: (GEODE TrackWise, SAP)
- Methods: AMDEC, Lean manufacturing, SMED
- Process flow analysis
Languages
French, Arabic
Native language
English
Advanced
C1
Spanish
Upper intermediate
B2
Timeline
Quality Director
LABEPIC Consulting
01.2020 - Current
CMO Quality Manager
GSK
01.2018 - 01.2020
Quality Assurance Manager
Atlas Pharm Tecnimede Group
01.2017 - 07.2018
Quality Assurance Coordinator
SOTHEMA
04.2013 - 03.2017
Primary packaging team leader
Sanofi Aventis
01.2012 - 03.2013
Process Engineer
Sanofi Aventis
08.2008 - 01.2012
Master of Science - Pharmacology
FACULTE DE PHARMACIE PARIS V
Bachelor of Science - Biochemistry
FACULTÉ FRANCHE COMPTE UFR Sciences Et Techniques
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